EP2438882B1 - Ensemble de découpe de fils pour une utilisation avec un cathéter - Google Patents

Ensemble de découpe de fils pour une utilisation avec un cathéter Download PDF

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Publication number
EP2438882B1
EP2438882B1 EP11183669.8A EP11183669A EP2438882B1 EP 2438882 B1 EP2438882 B1 EP 2438882B1 EP 11183669 A EP11183669 A EP 11183669A EP 2438882 B1 EP2438882 B1 EP 2438882B1
Authority
EP
European Patent Office
Prior art keywords
cutting
tracking
wire
catheter
distal
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Not-in-force
Application number
EP11183669.8A
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German (de)
English (en)
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EP2438882A1 (fr
Inventor
Israel Schur
James Erich Bressler
James F McGuckin Jr.
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Schur Israel
Rex Medical LP
Original Assignee
Schur Israel
Rex Medical LP
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US13/226,699 external-priority patent/US8685049B2/en
Priority claimed from US13/226,735 external-priority patent/US8685050B2/en
Application filed by Schur Israel, Rex Medical LP filed Critical Schur Israel
Publication of EP2438882A1 publication Critical patent/EP2438882A1/fr
Application granted granted Critical
Publication of EP2438882B1 publication Critical patent/EP2438882B1/fr
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22001—Angioplasty, e.g. PCTA
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A61B2017/22042—Details of the tip of the guide wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22061—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation for spreading elements apart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B2017/320733—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers

Definitions

  • This application relates to a system for treating stenotic lesions of a vessel and more particularly relates to a cutting wire for use with a catheter to open stenotic lesions in vessels.
  • stenotic lesions With stenotic lesions, the vessel diameter is constricted and therefore attempts have been made to widen this constriction.
  • One method is an invasive surgical procedure where the vessel wall is cut open and the portion containing the plaque or other constricting structure is removed. This procedure is traumatic, complex, and results in a long recovery time for the patient. It also causes a weakening of the vessel wall since a portion of the wall is removed. A weakened wall can ultimately result in an aneurysm which is a dilatation (expansion) of the artery, which adversely affects vessel function and if not surgically treated could be life threatening to the patient.
  • Balloon angioplasty is one such method.
  • a balloon is placed in the stenosed (restricted) portion of the vessel and inflated to compress the plaque against the vessel wall, thereby increasing the lumen in the vessel to improve blood flow. That is, the balloon is inflated to push the lesion radially outwardly to widen the passageway.
  • Some stenotic lesions are resistant to conventional pressure balloons. Consequently, high pressure balloons have been developed to treat resistant stenotic lesions. However, such high pressure balloons apply more force and increase the risk of vessel trauma and rupture. Moreover, sometimes lesions are even resistant to these high pressure balloons.
  • the surgeon may insert an angioplasty catheter, inflate the balloon and find that it is insufficient to widen the vessel passageway. The surgeon would then need to conduct the time consuming task of removing the catheter and inserting a cutting balloon catheter, threading it through the vascular system over a guidewire. Since the catheters are inserted from a remote site, e.g. through the femoral artery, these catheter exchanges take time and increase trauma to the patient. Additionally, it adds to the cost of the procedure since two catheters would be required. In order to properly treat the diverse size and condition of each lesion a large inventory of multiple sized cutting balloons would be required.
  • Such catheter exchanges might also require guidewire exchanges since the standard .035" (0.89 mm) guidewire utilized for an angioplasty catheter may be too large for the .018" (0.46 mm) cutting balloon catheter.
  • the guidewire exchanges complicate the procedure, increase the risk to the patient and increase the procedure time, thereby increasing costs to the patient.
  • U.S. Patent No. 7,131,981 attempts to address the foregoing issues by providing a conversion device comprising an insertion tube insertable into the normal .035" (0.89 mm) guidewire lumen of an angioplasty catheter.
  • This device would not work for angioplasty catheters with small guidewire lumens.
  • the tube has two jacket segments and a guide insert device having a channel and four guide channels. Because of the complexity of the device, the cutting elements in the four channels would need to be sufficiently thin to be maintained in the smaller diameter device. Such thin (small diameter) cutting elements however may be too flexible and not have adequate stiffness to be effective. Additionally, the cutting elements are attached at one end, having an opposite free end which can potentially damage and perforate the vessel wall during use.
  • WO2010003135 describes an apparatus that is operable in different modes to perform various functions for treating a body lumen.
  • the apparatus includes a shaft including a proximal end, a distal end, a lumen extending therebetween, and a balloon on the distal end having an interior communicating with the lumen.
  • the apparatus includes a valve on the distal end that selectively opens or closes an outlet communicating with the lumen. With the valve open, fluid introduced into the lumen exits the outlet into a body lumen. With the valve closed, fluid introduced into the lumen expands the balloon.
  • the apparatus also includes an actuator for axially compressing the balloon, and a helical member extends between ends of the balloon interior that expands the balloon from a contracted condition to an expanded helical shape when the actuator is activated.
  • the present invention overcomes the disadvantages and deficiencies of the prior art.
  • a device for treating a lesion in a body lumen to enlarge a passageway in the body lumen comprising at least one cutting member having a proximal portion and a distal portion, and a tracking member having a proximal portion and a distal portion, the cutting member and tracking member being in the form of elongate members with a longitudinal axis of the cutting member extending alongside a longitudinal axis of the tracking member and being connected at their distal portions and insertable into the body lumen as a unit, wherein the cutting member is unattached to the tracking member at all points proximal of the distal connection between the cutting member and the tracking member and is configured for movement in a direction transverse to the longitudinal axis of the tracking member to widen a gap between the cutting member and tracking member proximal of the connection at the distal portions, and wherein the lengths of the tracking member and the cutting member are such as to extend in use out of the body for insertion of a catheter
  • the cutting member has a cutting surface on a first surface opposite a second surface facing the tracking member.
  • the cutting surface may be formed only in a distal region of the cutting member.
  • the second surface may have a convex surface.
  • the tracking member includes a plurality of marker bands.
  • the cutting member at a cutting region is substantially triangular in cross-section.
  • only a distal region of the cutting member is provided with a cutting edge or surface, with the remaining proximal region thereof being atraumatic and non-cutting.
  • a height of the distal region may be less than a height of the remaining proximal region.
  • the tracking member has a coil at a distal tip.
  • the device further comprises a shrink wrap over a connection region of the tracking and cutting members.
  • the cutting member is a wire and the tracking member is a wire.
  • the cutting member is substantially circular in cross-section in a proximal region and substantially triangular in cross-section in a distal region.
  • the device may be used in combination with a catheter having a lumen, wherein the at least one cutting member includes a plurality of cutting members, the plurality of cutting members are connected at a distal portion to the tracking member and insertable as a unit through the lumen of the catheter.
  • the invention also relates to a combination of a device as hereinbefore defined and a catheter having a lumen and an expandable portion, wherein the cutting member has a cutting surface configured to treat the lesion to enlarge the passageway in the body lumen when moved by the expandable portion of the catheter to widen the gap between the cutting member and tracking member.
  • the expandable portion may comprise an inflatable balloon.
  • the cutting assembly of the present invention includes a cutting member (or element) and a tracking member (or element).
  • a cutting member or element
  • a tracking member or element
  • a single cutting member is provided; in alternative embodiments, multiple cutting members are provided.
  • the various devices of the present invention disclosed herein function to treat the stenotic lesion inside the vessel wall, thereby opening or enlarging the passageway in the vessel which was restricted.
  • the stenosis can be a result of plaque buildup, endothelial growth, blood clots, etc.
  • the device can also be used to treat other lesions restricting passageways in other body lumens.
  • an assembly 10 in accordance with one embodiment of the present invention includes a tracking member, designated generally by reference numeral 30 and preferably in the form of a wire, and a cutting member, designated generally by reference numeral 20 and preferably in the form of a wire.
  • the tracking wire 30 and cutting wire 20 are preferably attached at a distal portion so they are insertable as a unit.
  • the wire assembly 10, as described below, can be used with a conventional catheter, such as an angioplasty catheter.
  • cutting member in the form of a wire 20 has a distal portion 23 which is connected to a distal portion 32 of a tracking member in the form of a wire 30.
  • a distalmost tip 23 of the cutting wire 20 is attached to the tracking or guidewire 30.
  • One way of attachment is to twist the wires together.
  • Other methods of attachment are also contemplated such as welding, bonding or placement of a separate element such as a collar over the end of the wires to frictionally engage the wires.
  • the cutting wire 20 remains unattached proximal of the distal connection (attachment) region to enable it to be separated from the tracking wire 30, e.g. moved transversely with respect to the longitudinal axis of the tracking wire 30.
  • the initial position of the wires 20, 30 are shown; in Figures 5D and 5E the wires 20, 30 are further separated as described in detail below.
  • Tracking member has a coil tip 33 for flexibility.
  • a heat shrink wrap 35 can be placed over the connection region of the cutting wire 20 and a tracking wire 30.
  • Marker bands 34 can be provided for imaging.
  • tracking wire and cutting wire can be of substantially the same length, both extending out of the body for reinsertion of a catheter over the tracking wire as described below. Alternatively, they can be of different lengths.
  • the wire 70 is substantially triangular in cross section forming a V-shaped cutting surface 72 on a first surface opposite a second surface facing the tracking wire 30.
  • a cutting edge 76 on first surface 78a of cutting wire 78 with a substantially planar outer edge extends from the substantially planar base 79.
  • a surface 82 of the wire 80 opposite the cutting surface 84 and facing the tracking wire 30 is convex. This surface 82 can conform to the outer surface of the catheter balloon.
  • wire 88 is trapezoidal in cross section with a cutting surface 89 on the outer surface.
  • Other shapes are also contemplated, including but not limited to polygonal shapes that are substantially: square, rectangular, rhombus, hexagonal, pentagonal, octagonal, diamond shaped, etc.
  • a round or oval wire cross-section with a sharpened surface is also contemplated.
  • Caltrop shapes and upside down T-shapes are also contemplated. These wire shapes can be utilized in the various cutting wire embodiments disclosed herein.
  • the cutting wire member
  • only a portion of the cutting wire (member) can have the cutting edge or surface, e.g. the distal region, with a remaining portion being atraumatic and non-cutting.
  • wire 51 of cutting assembly 50 has a distal portion having a cutting edge 54.
  • Proximal of distal portion 52, the portion 56 is atraumatic and can be substantially circular in cross-section as shown in Figure 4B .
  • the distal region of wire 51 can be conical and can have an atraumatic surface. Note the height of the cutting surface region can be less than the height (e.g. diameter) of the atraumatic portion 56.
  • a coil such as coil 33 can be provided at the distal tip of tracking member (wire) 55.
  • Several marker bands 58 are provided on tracking wire 55 for imaging.
  • a heat shrink wrap such as shrink wrap 35 of Figure 1B which covers the distal and connecting region of wires 20 and 30 can be provided over the distal tip and connection region of the cutting and tracking wires 51, 55 of Figure 3B .
  • a conventional catheter 60 such as conventional angioplasty catheter, is inserted over a conventional guidewire G to the treatment site as shown in Figure 5 .
  • Guidewire G extends through a lumen 62 in the catheter 60.
  • Access to the vessel can be obtained through the femoral artery or vein for example.
  • the angioplasty catheter 60 has an inflatable balloon 64 which is in fluid communication with an inflation lumen of the catheter as is conventional. At the target site, inflation of the balloon 64 expands the balloon 64 to expand the lesion B and widen the lumen of the vessel V.
  • the wire assembly 10 (or assembly 50) of the present invention can be utilized.
  • the guidewire G is removed from the guidewire lumen 62 of the catheter 60 (see Figure 5A ) and the wire assembly 10 (or 50) is inserted through the lumen 62 as shown in Figure 5B .
  • the tracking guidewire 30 (or 55) and cutting wire 20 (or 51) of wire assembly 10 (or 50) are inserted to the target site.
  • the catheter 60 is removed from the treatment site and vessel, and removed from the body, leaving the wire assembly 10 at the target site as shown in Figure 5C .
  • the catheter 60 is then reinserted over proximal end of tracking wire 30.
  • a different balloon catheter or catheter with other expandable member
  • the catheter is inserted over the proximal portion of the tracking wire 30 such that the tracking wire 30 extends through the lumen 62; however, cutting wire 20 remains outside the lumen 62 and thus does not extend through lumen 62 as shown in Figure 5D .
  • the tracking wire 30 provides a guide for the catheter 60 to the target site, while the cutting wire 20 remains adjacent an outer surface of the catheter 60 for subsequent expansion into contact with the lesion. As shown in Figure 5D , there is an increased gap 65 between the cutting wire 20 and tracking wire 30 caused by the catheter 60 positioned between the two wires 20, 30.
  • the balloon 64 is inflated, forcing the cutting wire 20 radially and into contact with the lesion B so the cutting edge or surface can treat the lesion.
  • a mechanical expander or other structure can be used to force the cutting wire 20 into contact with the lesion.
  • the balloon 64 can be deflated and the wire assembly easily rotated to another position for subsequent transverse movement by the cutting wire into contact with another region of the lesion B. In this manner, the select portions of the stenosis can be treated, as the cutting wire 20 is expanding in one direction.
  • the cutting wire assembly 50 can be used in a similar manner.
  • the method described above utilizes the same catheter for the initial step ( Figure 5 ) as well as for the subsequent step of reinsertion for placement only over the tracking wire 30 ( Figure 5D ).
  • a different catheter can be used for insertion over tracking wire 30 in the step of Figure 5D .
  • cutting assembly 110 of one embodiment includes a tracking member, designated generally by reference numeral 140, preferably in the form of a wire, and two cutting members, designated generally by reference numerals 120 and 130, and preferably in the form of wires.
  • the tracking wire 140 and cutting wires 120, 130 are preferably attached at a distal portion so they are insertable as a unit.
  • the wire assembly 110 can be used with a conventional catheter, such as an angioplasty catheter.
  • two cutting wires are shown in Figure 6 , spaced about 180 degrees apart, different spacing is also contemplated. Additionally, more than two cutting wires can be provided, e.g.
  • the three cutting wires 180, 181, 182 of Figure 9A can be equidistantly spaced apart encircling tracking wire 190 as shown or spaced at different distances.
  • the first cutting member is in the form of a wire 120 and has a distal portion 122 which is connected to a distal portion 142 of a tracking member in the form of a wire 140.
  • a distalmost tip 123 of the cutting wire 120 is attached to the tracking guidewire 140.
  • the second cutting member is in the form of a wire 130 and has a distal portion 132 which is connected to the distal portion 142 of the tracking member 140.
  • a distalmost tip 133 of the cutting wire 130 is attached to the tracking guidewire 140.
  • One way of attachment of the wires 120, 130 to wire 140 is to twist the wires together.
  • a coil 157 can be provided at the tip such as illustrated in Figure 6 .
  • Several marker bands 158 can be provided on tracking wire 140 for imaging.
  • a shrink wrap 153 can be provided over the connection region of the tracking wire 140' and cutting wires 120', 130' of cutting assembly 110'.
  • the cutting assembly 110' can also include a coil similar to coil 157 and a shrink wrap similar to shrink wrap 153.
  • tracking wire and cutting wires can be of substantially the same length, both extending out of the body for reinsertion of a catheter over the tracking wire as described below. Alternatively, they can be of different lengths.
  • the wires 120, 130 are substantially circular in cross-section until a transition region, i.e. region 125, where it transitions to a wire substantially triangular in cross section forming a V-shaped cutting surface 127 on a first surface opposite a second surface 129 facing the tracking wire 140 ( Figure 8 ).
  • a concave or convex surface can be formed on one, two or all three sides (see e.g. wire 170 of Figure 8A ).
  • a convex surface on the side opposite the cutting edge helps to conform to the outer surface of the catheter balloon.
  • FIG. 8C a rhombus shaped wire 180 is illustrated. This shape facilitates cutting if the cutting wire is rotated.
  • Figure 8D illustrates a caltrop shape wire 184 configured so that one point will always point upward.
  • Figure 8E illustrates an upside down T-shape wire 188. The base of wire 188 can be convex.
  • cutting wire 130 has the same configuration as cutting wire 120. However, in alternate embodiments, the cutting wire 130 can have an alternate configuration, including but not limited to, any of the foregoing cross-sectional wire shapes.
  • the cutting wires 120, 130 can have the cutting edge or surface, e.g. the distal region, with a remaining portion being atraumatic and non-cutting. This is illustrated in Figure 7 , where the circular cross-section at a more proximal region is atraumatic. Note a region distal of the cutting portion can be atraumatic, e.g. can transition back to a substantially circular cross-section.
  • the wires can also have a conical tip as in the embodiment of Figure 3B .
  • Wire assembly 110 would be used in the same manner.
  • a conventional angioplasty catheter 100 is inserted over a conventional guidewire G to the treatment site as shown in Figure 11 .
  • Guidewire G extends through a lumen 102 in the catheter 100.
  • Access to the vessel can be obtained through the femoral artery or vein for example.
  • the angioplasty catheter 100 has an inflatable balloon 104 which is in fluid communication with an inflation lumen of the catheter as is conventional. At the target site, inflation of the balloon 104 expands the balloon to expand the lesion B and widen the lumen of the vessel V.
  • the wire assembly 110 (or 110') of the present invention can be utilized.
  • the guidewire G is removed from the guidewire lumen 102 of the catheter 100 (see Figure 11B ) and the wire assembly 110 is inserted through the lumen 102 as shown in Figure 11B .
  • the tracking guidewire 140 and cutting wires 120, 130 of wire assembly 110 are inserted to the target site.
  • the catheter 100 is removed from the treatment site and vessel, and removed from the body, leaving the wire assembly 110 at the target site as shown in Figure 11C .
  • the catheter 100 is then reinserted over the proximal end of tracking wire 140.
  • a different balloon catheter can be inserted instead of reinserting the same catheter used in the step of Figure 11 .
  • the catheter 100 is inserted over the proximal portion of the tracking wire 140 such that the tracking wire 140 extends through the lumen 102; however, cutting wires 120 and 130 remain outside the lumen 102 as shown in Figure 11D .
  • the tracking wire 140 provides a guide for the catheter 100 to the target site, while the cutting wires remain adjacent an outer surface of the catheter 100 for subsequent expansion into contact with the lesion.
  • the balloon 104 is inflated, forcing the cutting wires 120 and 130 into contact with the lesion B so the cutting edge or surface can treat the lesion.
  • a mechanical expander or other structure can be used to force the cutting wires 120, 130 radially and into contact with the lesion.
  • the balloon 104 can be deflated and the wire assembly easily rotated to another position for subsequent transverse movement of the cutting wires by the balloon into contact with another region of the lesion B to treat select portions of the stenosis.
  • the method described above utilizes the same catheter for the initial step ( Figure 11 ) as well as for the subsequent step of reinsertion for placement only over the tracking wire 140 ( Figure 11D ).
  • a different catheter can be used for reinsertion over only the tracking wire 140.
  • a single balloon is utilized to expand both wires substantially simultaneously. It is also contemplated that a separate balloon or separate expansion of the single balloon can be used to move the wires 120, 130 independently/separately.
  • wire assemblies disclosed herein can accommodate balloon catheters having relatively small guidewire lumens.
  • the devices disclosed herein can also be used to remove other structures constricting the passageway in the vessel or in other body lumens.
  • the cutting and tracking components are illustrated as wires, but other structures for the cutting member and tracking member are also contemplated such as a hard plastic tube or a metal hypotube.
  • the metal hypotube can be formed with a cutting surface or alternatively have a cutting member such as a cutting tube attached thereto.
  • the cutting wire assemblies of the present invention as described can be used in various vessels including for example, veins such as the femoral veins, grafts such as dialysis grafts, etc.
  • Other vessels are also contemplated such as use in carotid arteries, coronary arteries, the descending aorta and renal arteries, the external iliac and internal iliac arteries and the common femoral and deep femoral arteries.
  • Applications for the devices disclosed herein include, but are not limited to, treating stenotic venous and arterial anastomosis, lesions resistant to conventional angioplasty, stent restenosis, and vessels with buildup of intima, etc.

Claims (15)

  1. Dispositif destiné à traiter une lésion dans une lumière corporelle pour agrandir un passage dans la lumière corporelle, le dispositif comprenant au moins un élément de coupe (20, 120, 120', 130', 130) présentant une partie proximale et une partie distale (23, 122, 132), et un élément de suivi (30, 140) présentant une partie proximale et une partie distale (142), l'élément de coupe et l'élément de suivi se présentant sous forme d'éléments allongés avec un axe longitudinal de l'élément de coupe s'étendant le long d'un axe longitudinal de l'élément de suivi et étant connectés au niveau de leurs parties distales et insérables dans la lumière corporelle en tant que tout, caractérisé en ce que l'élément de coupe n'est pas attaché à l'élément de suivi (30, 140) à tous les points de la connexion distale entre l'élément de coupe et l'élément de suivi et est configuré pour se déplacer dans un sens transversal à un axe longitudinal de l'élément de suivi pour élargir un espace entre l'élément de coupe et l'élément de suivi proximal à la connexion au niveau des parties distales, et en ce que les longueurs de l'élément de suivi et de l'élément de coupe sont telles qu'elles s'étendent en service en dehors du corps pour l'insertion d'un cathéter par-dessus l'élément de suivi.
  2. Dispositif selon la revendication 1, dans lequel l'élément de coupe (20, 120) présente une surface de coupe (72, 127) sur une première surface opposée à une seconde surface (129) faisant face à l'élément de suivi (30, 140).
  3. Dispositif selon la revendication 2, dans lequel la surface de coupe est formée uniquement dans une région distale de l'élément de coupe.
  4. Dispositif selon la revendication 2 ou 3, dans lequel la seconde surface présente une surface convexe.
  5. Dispositif selon n'importe quelle revendication précédente, dans lequel l'élément de suivi (30, 140) comporte une pluralité de bandes repères (34, 58, 158).
  6. Dispositif selon n'importe quelle revendication précédente, dans lequel l'élément de coupe (20) au niveau d'une région de coupe (70, 80, 85) présente une coupe transversale sensiblement triangulaire.
  7. Dispositif selon n'importe quelle revendication précédente, dans lequel seule une région distale de l'élément de coupe (20) est pourvue d'un bord de coupe ou d'une surface de coupe (54), la région proximale restante (56) de celui-ci étant atraumatique et non coupante.
  8. Dispositif selon la revendication 7, dans lequel une hauteur de la région distale est inférieure à une hauteur de la région proximale.
  9. Dispositif selon n'importe quelle revendication précédente, dans lequel l'élément de suivi (30, 140) présente une bobine (33, 157) au niveau d'une pointe distale.
  10. Dispositif selon n'importe quelle revendication précédente, comprenant en outre un film thermorétractable (35, 153) sur une région de connexion des éléments de suivi et de coupe (30, 140', 20, 120', 130').
  11. Dispositif selon n'importe quelle revendication précédente, dans lequel l'élément de coupe (20, 120, 130) est un fil métallique (51, 70, 170, 175, 180, 181, 182, 184, 188) et l'élément de suivi (30, 140) est un fil métallique (55).
  12. Dispositif selon n'importe quelle revendication précédente, dans lequel l'élément de coupe (20, 120, 130) présente une coupe transversale sensiblement circulaire dans une région proximale (56) et une coupe transversale sensiblement triangulaire dans une région distale (51).
  13. Combinaison d'un dispositif selon n'importe quelle revendication précédente avec un cathéter (100) présentant une lumière, dans laquelle l'au moins un élément de coupe comporte une pluralité d'éléments de coupe (120, 130), la pluralité d'éléments de coupe étant connectée au niveau d'une partie distale (142) à l'élément de suivi (140) et pouvant être insérée en tant que tout à travers la lumière du cathéter (100).
  14. Combinaison d'un dispositif selon l'une quelconque des revendications 1 à 12 avec un cathéter (60, 100) présentant une lumière (62, 102) et une partie extensible (64, 104), dans lequel l'élément de coupe (20, 120, 120', 130, 130') présente une surface de coupe configurée pour traiter la lésion afin d'agrandir le passage dans la lumière corporelle quand il est déplacé par la partie extensible du cathéter pour élargir l'espace entre l'élément de coupe et l'élément de suivi (30, 140).
  15. Combinaison selon la revendication 14, dans lequel la partie extensible (64, 104) comprend un ballon gonflable.
EP11183669.8A 2010-10-06 2011-10-03 Ensemble de découpe de fils pour une utilisation avec un cathéter Not-in-force EP2438882B1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US39021710P 2010-10-06 2010-10-06
US41493110P 2010-11-18 2010-11-18
US13/226,699 US8685049B2 (en) 2010-11-18 2011-09-07 Cutting wire assembly for use with a catheter
US13/226,735 US8685050B2 (en) 2010-10-06 2011-09-07 Cutting wire assembly for use with a catheter

Publications (2)

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EP2438882A1 EP2438882A1 (fr) 2012-04-11
EP2438882B1 true EP2438882B1 (fr) 2019-07-24

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Publication number Priority date Publication date Assignee Title
CN105664338A (zh) * 2016-04-26 2016-06-15 业聚医疗器械(深圳)有限公司 球囊导管
EP3664731B1 (fr) 2018-08-06 2021-02-24 C. R. Bard, Inc. Cathéter avec dispositif de coupe guidé, déplaçable pour découpe/incision active
US20230397925A1 (en) * 2020-11-06 2023-12-14 Bard Peripheral Vascular, Inc. Balloon catheter with selective scoring capability

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US5196024A (en) 1990-07-03 1993-03-23 Cedars-Sinai Medical Center Balloon catheter with cutting edge
WO1998019608A1 (fr) * 1996-11-07 1998-05-14 Vascular Science Inc. Instrument medical a anse extensible
CA2504135C (fr) * 2002-11-01 2012-01-31 C.R. Bard, Inc. Catheter a embout conique, court, a profil bas
US7131981B2 (en) 2003-03-25 2006-11-07 Angiodynamics, Inc. Device and method for converting a balloon catheter into a cutting balloon catheter
GB0307715D0 (en) * 2003-04-03 2003-05-07 Ethicon Endo Surgery Inc Guide wire structure for insertion into an internal space
AU2009266808B2 (en) * 2008-07-03 2014-07-10 Teleflex Life Sciences Limited Apparatus and methods for treating obstructions within body lumens
JP5770087B2 (ja) * 2008-07-25 2015-08-26 スパイン ビュー， インコーポレイテッド ケーブルベースの創傷清拭のためのシステムおよび方法
US20100057077A1 (en) * 2008-09-02 2010-03-04 Wilson-Cook Medical Inc. Fep pre-curved distal tip sphincterotome

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Title
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CA2754315C (fr) 2019-01-29
EP2438882A1 (fr) 2012-04-11

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